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NCT Number: NCT06722222

Gao's Triple Eversion Carotid Endarterectomy

Carotid endarterectomy (CEA), an important surgical approach for managing carotid plaque, has evolved over more than 70 years but still cannot be applied to all tandem carotid lesions (TCLs) because of the wide range of these lesions. Herein, the investigators introduce an innovative CEA, Gao's triple eversion CEA (GTE-CEA), for the treatment of TCLs.

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Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310050, China

Location status: Recruiting

Location contact

Zhiwei Gao, Doctor

CONTACT

[email protected]

17357161850 ext. 86

About this study

The investigators retrospectively reviewed the charts of patients who underwent GTE-CEA performed by the same group of vascular surgeons since 17 September, 2021. Patients who did not meet the diagnostic criteria for carotid artery stenosis (CAS); those with asymptomatic CAS < 50%, preoperatively confirmed by digital subtraction angiography (DSA) or computed tomography angiography (CTA); and those with stenosis at the opening of the common carotid artery (CCA) were excluded from our study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Meet the diagnostic criteria for TCL stenosis.
Above 70% asymptomatic CCA and ICA stenosis or > 50% symptomatic CAS confirmed by DSA or CTA before surgery

Exclusion criteria

Did not meet the diagnostic criteria for CAS
Asymptomatic CAS < 50% (as confirmed by DSA or CTA before surgery)
With stenosis at the opening of the CCA.

Treatment and study plan

Gao's triple eversion carotid endarterectomy

Procedure

The carotid sheath is dissected in front of the sternocleidomastoid muscle to expose sufficient lengths of the CCA, ECA, and ICA. After raising the systolic blood pressure to 180 mmHg and intravenously injecting 1 mg/kg heparin, the superior thyroid artery is lapped and severed, and the CCA is occluded proximally to the CCA plaque, based on the plaque location shown by preoperative CTA and by intraoperative arterial exploration. Subsequently, the ECA and ICA are blocked individually. The ICA is cut diagonally at the CCA fork and the ECA is transected approximately 5 mm above its beginning. The plaque is removed with tweezers after eversion of the ICA. This process is repeated for the ECA. Finally, the long segment of plaque in the CCA is stripped proximally, followed by thorough removal of the debris on the peeling surface using heparin irrigation.

Primary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: Until the end of the study, an average of 3 years

Digital subtraction angiography (DSA) or computed tomography angiography showed carotid artery recanalization and no risk complications such as stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Jinren Zhou, Dr.

CONTACT

[email protected]

15995090018 ext. 86

Zhiwei Gao, Dr.

CONTACT

[email protected]

17357161850 ext. 86

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A New Surgical Method for Treating Tandem Carotid Lesions: Gao's Triple Eversion Carotid Endarterectomy

Important dates

Study start: 2021
Primary completion: 2031
Study completion: 2031
First posted: Dec 9, 2024
Registry last updated: Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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